Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
NCT ID: NCT00040378
Last Updated: 2018-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4246 participants
OBSERVATIONAL
2002-05-31
2016-08-31
Brief Summary
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Detailed Description
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Only participants who are taking part in the SELECT study (a study that looks at the use of vitamin E and selenium for preventing prostate cancer) may apply to participate in the PREADVISE study about how useful vitamin E and selenium might be for preventing memory changes with age (including Alzheimer's disease and other disease that can affect the brain). African American and Hispanic men who are age 60 or older may take part. Men of other ethnic groups aged 62 or older may take part. The SELECT doctors or staff will review the applicant's medical history and drugs to verify that they have no conditions that would exclude them from this study. About 10,000 men will take part in this study.
The PREADVISE study examinations will be done during the participant's annual SELECT visit at the clinic where the SELECT studies are being conducted. There will be one study visit for each year the participants are in SELECT (7 to 12 visits). Each visit for PREADVISE will consist of a brief screening of the participant's memory, and an update (if any) of the participant's family history of dementia and medications. If memory changes are suggested by the brief memory screen, the participant will be asked to take a longer memory screen to further evaluate the potential for memory changes. If the longer memory screen also suggests problems with the participant's memory, the participant will be asked to see his family doctor or a PREADVISE doctor for a more complete medical exam to find the possible causes of the memory change. Results of the doctor's medical exam, with the consent of the participant, will be sent to the PREADVISE doctors for their review to help with the diagnosis. Results of the memory checks will not be given to the participants. However, if the participant does have a medical workup for memory changes, this information will be given to the family doctor after the medical workup is completed. A portion of the blood sample that was taken when the participant entered SELECT might be analyzed and tested for a genetic risk factor associated with Alzheimer's disease, called Apolipoprotein E (ApoE). The results of this test will be used for research purposes only.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Combination therapy
vitamin E (alphatocopherol) and selenium
alphatocopherol
400 IU daily
Selenium
200mcg daily
Vitamin E only
vitamine E (alphatocopherol) and placebo
alphatocopherol
400 IU daily
Placebo replacement for Selenium
1 placebo pill daily
Selenium only
selenium and placebo (Placebo replacement for vitamin E)
Selenium
200mcg daily
Placebo replacement for vitamin E
1 placebo pill daily
Placebo
placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
Placebo replacement for vitamin E
1 placebo pill daily
Placebo replacement for Selenium
1 placebo pill daily
Interventions
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alphatocopherol
400 IU daily
Selenium
200mcg daily
Placebo replacement for vitamin E
1 placebo pill daily
Placebo replacement for Selenium
1 placebo pill daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 62 years or older if other ethnic origin, or 60 years or older if African-American or Hispanic;
* General good health with no neurological or psychiatric illness.
Exclusion Criteria
* Alzheimer's disease, or any other form of dementia such as Pick's disease, dementia with Lewy bodies, frontotemporal dementia, vascular dementia, significant cognitive and motor impairment from a stroke or corticobasal degeneration;
* Huntington's disease, epilepsy, Parkinson's disease, brain tumor, multiple sclerosis, manic-depressive disorder, or schizophrenia;
* The participant must not have had a head injury with prolonged loss of consciousness (over 30 minutes) within the past five years;
* The participant must not have a current alcohol or substance abuse diagnosis, or must have been treatment free for the past 24 months;
* The participant must not have had a diagnosis of depression or anxiety disorder in the past 4 months and must not currently be under treatment for depression or anxiety disorder. \[A participant who was previously diagnosed with depression or anxiety disorder but completed treatment more than four months ago is eligible.\];
* The participant must not currently use of any of the following medications: Aricept, Cognex, Exelon, Reminyl, or Hydergine;
* The participant must not have blindness, deafness, language difficulties or any other disability that may prevent completion of the memory screen.
60 Years
90 Years
MALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
National Cancer Institute (NCI)
NIH
Frederick Schmitt
OTHER
Responsible Party
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Frederick Schmitt
Principal Investigator
Principal Investigators
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Frederick Schmitt, PhD
Role: PRINCIPAL_INVESTIGATOR
Sanders-Brown Center on Aging
Richard Kryscio, PhD
Role: PRINCIPAL_INVESTIGATOR
Sanders-Brown Center on Aging
Locations
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University of Alabama at Birmingham Preventive Medicine
Birmingham, Alabama, United States
Alaska Regional Hospital
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
University of California, San Diego - Chula Vista
Chula Vista, California, United States
Glendale Memorial Hospital
Glendale, California, United States
University of California, San Diego
La Jolla, California, United States
VA Medical Center
Loma Linda, California, United States
VAMC Long Beach
Long Beach, California, United States
Northridge Hospital Medical Center
Northridge, California, United States
Santa Rosa Memorial Hospital Regional CCOP
Santa Rosa, California, United States
LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Lionel B. Katchem
Upland, California, United States
Rocky Mountain CC/Poudre Valley Hospital
Fort Collins, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
DC United MBCCOP
Washington D.C., District of Columbia, United States
Baptist Medical Center
Jacksonville, Florida, United States
Kaiser Southeast Permanente Medical Group
Tucker, Georgia, United States
Bliss Cancer Center/McFarland Clinic/Mary Greely MC
Ames, Iowa, United States
Cedar Rapids CCOP
Cedar Rapids, Iowa, United States
Genesis Medical Center
Davenport, Iowa, United States
Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Stormont-Vail Health Care/Cotton O'Neil Clinic
Topeka, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Our Lady of Bellefonte Hospital Inc.
Ashland, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Louisville VA Medical Center
Louisville, Kentucky, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Berkshire Hematology Oncology/Bershire Medical Center
Pittsfield, Massachusetts, United States
Bixby Oncology Center
Adrian, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Grand Rapids Clinical Oncology Program CCOP
Grand Rapids, Michigan, United States
Monroe Clinic
Monroe, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Duluth CCOP
Duluth, Minnesota, United States
St. John's Regional Medical Center
Joplin, Missouri, United States
St. John's Health System
Springfield, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Benefis Health Care
Great Falls, Montana, United States
Good Samaritan Health Systems - Cancer Center
Kearney, Nebraska, United States
Cancer Resource Center
Lincoln, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Missouri Valley Cancer Cons CCOP/Creighton University
Omaha, Nebraska, United States
Washoe Medical Center
Reno, Nevada, United States
VAMC New Jersey Health Care System
East Orange, New Jersey, United States
Warren Hospital
Phillipsburg, New Jersey, United States
Riverview Medical Center
Red Bank, New Jersey, United States
Stratton Veterans Affairs Medical Center
Albany, New York, United States
Bassett Research Institute
Cooperstown, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Columbus CCOP
Columbus, Ohio, United States
Fremont Memorial Hospital
Fremont, Ohio, United States
NW Ohio Oncology Center/St. Luke's Hospital
Maumee, Ohio, United States
St. Charles Hospital
Oregon, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Medical Center
Toledo, Ohio, United States
Toledo CCOP
Toledo, Ohio, United States
Toledo Clinic Inc.
Toledo, Ohio, United States
Muskogee Regional Medical Center
Muskogee, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
York Cancer Center/Wellspan Health
York, Pennsylvania, United States
Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Methodist Regional Cancer Center
Oak Ridge, Tennessee, United States
Methodist Hospitals of Dallas
Dallas, Texas, United States
Scott & White CCOP
Temple, Texas, United States
Cascadia Clinical Trials at St. Joseph Hospital
Bellingham, Washington, United States
Virginia Mason CCOP
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Northwest Hospital
Seattle, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Sinai Samaritan Medical Center
Milwaukee, Wisconsin, United States
Ottawa General Hospital
Ottawa, Ontario, Canada
San Juan Dr. I. Gonzalez Martinez/Centro Medico
San Juan, , Puerto Rico
Altamira Family Medicine
San Juan, , Puerto Rico
Centro Clinico San Patricio
San Juan, , Puerto Rico
Miguel Sosa Padilla, MD/San Juan City Hospital
San Juan, , Puerto Rico
VAMC San Juan
San Juan, , Puerto Rico
San Juan City Hospital - PR, Hematology Oncology Office
San Juan, , Puerto Rico
Countries
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References
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Lovell MA, Ehmann WD, Butler SM, Markesbery WR. Elevated thiobarbituric acid-reactive substances and antioxidant enzyme activity in the brain in Alzheimer's disease. Neurology. 1995 Aug;45(8):1594-601. doi: 10.1212/wnl.45.8.1594.
Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22. doi: 10.1056/NEJM199704243361704.
Markesbery WR, Carney JM. Oxidative alterations in Alzheimer's disease. Brain Pathol. 1999 Jan;9(1):133-46. doi: 10.1111/j.1750-3639.1999.tb00215.x.
Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
Mathews M, Abner E, Caban-Holt A, Dennis BC, Kryscio R, Schmitt F. Quality of education and memory test performance in older men: the New York University Paragraph Recall Test normative data. Curr Alzheimer Res. 2013 Sep;10(7):776-83. doi: 10.2174/15672050113109990140.
Kryscio RJ, Abner EL, Schmitt FA, Goodman PJ, Mendiondo M, Caban-Holt A, Dennis BC, Mathews M, Klein EA, Crowley JJ; SELECT Investigators. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial. J Nutr Health Aging. 2013 Jan;17(1):72-5. doi: 10.1007/s12603-012-0083-3.
Abner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217.
Caban-Holt A, Abner E, Kryscio RJ, Crowley JJ, Schmitt FA. Age-expanded normative data for the Ruff 2&7 Selective Attention Test: evaluating cognition in older males. Clin Neuropsychol. 2012;26(5):751-68. doi: 10.1080/13854046.2012.690451. Epub 2012 May 31.
Ding X, Kryscio RJ, Turner J, Jicha GA, Cooper G, Caban-Holt A, Schmitt FA, Abner EL. Self-Reported Sleep Apnea and Dementia Risk: Findings from the Prevention of Alzheimer's Disease with Vitamin E and Selenium Trial. J Am Geriatr Soc. 2016 Dec;64(12):2472-2478. doi: 10.1111/jgs.14393. Epub 2016 Nov 1.
Abner EL, Kryscio RJ, Caban-Holt AM, Schmitt FA. Baseline subjective memory complaints associate with increased risk of incident dementia: the PREADVISE trial. J Prev Alzheimers Dis. 2015 Mar;2(1):11-16. doi: 10.14283/jpad.2015.37.
Kryscio RJ, Abner EL, Caban-Holt A, Lovell M, Goodman P, Darke AK, Yee M, Crowley J, Schmitt FA. Association of Antioxidant Supplement Use and Dementia in the Prevention of Alzheimer's Disease by Vitamin E and Selenium Trial (PREADViSE). JAMA Neurol. 2017 May 1;74(5):567-573. doi: 10.1001/jamaneurol.2016.5778.
Ding X, Abner EL, Schmitt FA, Crowley J, Goodman P, Kryscio RJ. Mental Component Score (MCS) from Health-Related Quality of Life Predicts Incidence of Dementia in U.S. Males. J Prev Alzheimers Dis. 2021;8(2):169-174. doi: 10.14283/jpad.2020.50.
Related Links
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Clinicaltrials.gov SELECT trial record
Southwest Oncology Group
Other Identifiers
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IA0033
Identifier Type: -
Identifier Source: org_study_id
NCT00780689
Identifier Type: -
Identifier Source: nct_alias
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